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A phase I/II study to evaluate the safety, tolerability and early efficacy of MGV354 in healthy subjects and in patients with ocular hypertension or glaucoma

Stacy, Rebecca and Huttner, Kenneth and Watts, Jen and Peace, James and Wirta, David and Walters, Tom and Sall, Kenneth and Seaman Iii, John and Ni, Xiao and Prasanna, Ganesh and Mogi, Muneto and Adams, Christopher and Yan, Jing-He and Wald, Michael and He, Yunsheng and Newton, Ronald and Kolega, Randall and Grosskreutz, Cyndy (2018) A phase I/II study to evaluate the safety, tolerability and early efficacy of MGV354 in healthy subjects and in patients with ocular hypertension or glaucoma. American Journal of Ophthalmology.

Abstract

Purpose: To assess the clinical safety, tolerability, and efficacy of topically administered MGV354, a soluble guanylate cyclase (sGC) activator, in patients with ocular hypertension (OH) or glaucoma.
Design: Double-masked, prospective, randomized and vehicle-controlled three-part multicenter study with 98 subjects (ClinicalTrials.gov NCT02743780).
Methods: Parts 1 and 2 evaluated safety and tolerability to identify the maximum tolerated dose (MTD) of once daily MGV354 in 32 healthy volunteers (Part 1) and 16 patients with OH or glaucoma (Part 2). Part 3 evaluated IOP-lowering efficacy of the MTD administered nightly for one week in 50 patients with minimum IOP of 24mm Hg at 8 AM, with a main outcome measure of mean diurnal IOP at Day 8 compared to baseline.
Results: There was no difference in favor of MGV354 for IOP lowering; change from Baseline to Day 8 in mean diurnal IOP was -0.6 mmHg for MGV354-treated patients and -1.1 mmHg for Vehicle-treated patients in Part 3, with a confidence interval of -0.7 to 1.7. The most common AEs reported following MGV354 administration in all the three parts was conjunctival and ocular hyperemia.
Conclusions: Overall, MGV354 0.1% demonstrated no statistically significant effect compared to Vehicle in lowering IOP based upon the study’s main outcome measure. MGV354 produced ocular hyperemia consistent with target engagement in the conjunctiva, but human glaucomatous trabecular meshwork may have levels of oxidized sGC that are too low to benefit from MGV354.

Item Type: Article
Date Deposited: 20 Jun 2018 00:45
Last Modified: 20 Jun 2018 00:45
URI: https://oak.novartis.com/id/eprint/34838

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